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On March 13, 2017, the board of directors of Agencia Nacional De Vigilancia Sanitari’s (ANVISA) announced that they had reached a new agreement with the Brazilian Patent Office, namely, the Instituto Nacional da Propriedade Industrial (INPI), concerning the prior approval provision under Article 229-C of the Brazilian Patent Statute (For more information about the 229-C article, please see our posts here, here, and here). On April 12, 2017, after an event with several authorities and President Michel Temer, ANVISA and INPI published a written version of the new joint guidelines #1/2017 (translation enclosed here:INTERAGENCY ORDINANCE). These guidelines describe the new workflow between ANVISA and INPI involving the examination of pharmaceutical patent applications.

Article 4 of the guidelines establishes that ANVISA will analyze whether a patent application is contrary to public health.According to Article 4, a patent application claiming a product or process is considered to be contrary to public health when the product or process presents a “health risk”.The article further states that the “health risk” will be characterized when the pharmaceutical product comprises, or the pharmaceutical process results in a substance that has been prohibited in the country”.

If a product or process is found to pose a “health risk” (as defined in the Annex I of the Ministry of Health’s Ordinance #344 of 1998), ANVISA will deny prior approval and will send the application back to INPI for further handling. At this point, INPI will publish the definitive dismissal of the application. In other words, the application is denied.

The guidelines contain a new approach in the examination of patent applications claiming pharmaceutical products and processes of interest under the Brazilian government’s drug policies and pharmaceutical assistance of the National Healthcare System (SUS). Under Article 5, ANVISA will examine these applications of interest and prepare a “technical” opinion as to whether the claims meet the patentability requirements under Brazilian law.This opinion will be sent to INPI for use as a third-party observation under Article 31 of the Patent Statute of 1996.Once INPI receives ANVISA’s opinion, it is “free” to decide whether or not to agree with it. In the event INPI disagrees with ANVISA’s opinion and grants the patent application, it will send ANVISA a list containing all granted patents and will continue to make this list available to ANVISA (Article 7 of the guidelines).

The guidelines do not contain any information as to what ANVISA can or should do with the list of granted patents received from INPI.Actions that ANVISA could take include filing a post-grant opposition or seeking invalidity of the patent before Federal Courts.

Article 9 of the guidelines creates an Interagency Group between the two agencies. The purpose of this group is to seek to “harmonize” the understanding between the ANVISA and INPI regarding the application of patent law in “polemic” topics such as Markush claiming, selection inventions, the patentability of new uses, salts, polymorphs and antibodies, as well as other issues relevant to the pharmaceutical industry.One concern is that such “harmonization” could result in an unlawful administrative ban of claims that are currently being allowed INPI. As such, Article 9 gives ANVISA power to influence the INPI in a multitude of ways.

Additionally, it is important to note that the new guidelines come after several decisions were obtained against ANVISA by various pharmaceutical companies (See our post here) holding that that the agency lacked the statutory authorization to examine patentability requirements under Brazilian law. After these early decisions were rendered (which held that ANVISA’s prior approval review was restricted solely to the analysis of potential public health issues and not patentability requirements), ANVISA amended its guidelines to include a provision stating that “the granting of patents that do not fulfil the patentability requirements violates public health”. This change was interpreted by the courts as an attempt by the agency to escape the unfavorable case law and avoid the new guidelines.

As a whole, the guidelines read like an attempt by ANVISA to revive its ability to participate in the examination of pharmaceutical patent applications. Interestingly, many the associations representing generic companies in Brazil such as ABIFINA and Pro Generics are celebrating the guidelines as a victory for the local industry.

Continue to watch the BRIC Wall Blog for continuing updates on these new guidelines in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho from Licks Attorneys.

On March 15, 2017, the Sao Paulo State Court of Appeals confirmed a preliminary injunction barring Uniao Quimica, a Brazilian generic company, from launching a generic version of Allergan’s Combigan® (brimonidine tartrate and timolol maleate).Combigan® is prescribed for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.

The preliminary injunction was granted in view of three patent applications filed by Allergan and pending before the Instituto Nacional da Propriedade Industrial (INPI) since 2003 (namely, patent application no. PI0302584-5 filed in 2003 as well as divisional application nos. BR1220140116901-9 and BR122014016915-9 filed in 2012).Application no. PI0302584-5 was rejected by INPI; however, an administrative appeal is pending.

Allergan argued that the backlog and inefficiency of INPI had been punishing to the pharmaceutical company. Specifically, Allergan argued that not granting the preliminary injunction based on the pending application would be “allowing third parties to freely infringe the application during its pendency”, and that the “patent owner would be absolutely deprived of effective means to protect its invention during the prosecution of the application, a proceeding the patent owner has no control over”.

After the Trial Court issued an injunction on September 28, 2016, Uniao Quimica filed an interlocutory appeal challenging the grounds of the decision. The reporting Appellate Judge, Hon. Francisco Loureiro, stayed the injunction concluding that the patent owner was only allowed to exclude others based on its patent rights after issuance of the patent by INPI.

However, in a split decision (2-1), other members of the panel dissented from Hon. Loureiro, thus rejecting the interlocutory appeal and confirming the preliminary injunction. The Hon. Cesar Ciampolini issued the deciding vote, stating that the preliminary injunction should be granted for the following reasons: (i) INPI’s inexcusable delay in examining patent applications; (ii) the rapid pace at which technology becomes obsolete; (iii) counterpart patents has been granted in several countries; (iv) Uniao Quimica did not deny that its products were copies of Combigan®; and (v) Uniao Quimica’s behavior in launching generic copies was a matter of unfair competition and should not be allowed by the courts.

Although Uniao Quimica may still appeal to higher courts, the decision is an interesting outcome in view of INPI’s backlog in examining patent application.

Please continue to watch the BRIC Wall Blog for updates on the examination of patent applications by INPI.

This post was written by Lisa Mueller, Felipe Mesquita and Roberto Rodrigues Pinho of Licks Attorneys.

In the second half of 2016, two very interesting decisions were issued by the federal courts in Brazil against the Brazilian Food and Drug Agency (ANVISA) involving the prior approval of patent applications claiming pharmaceutical products.These decisions bring some very good news to pharmaceutical patent owners who have struggled for years with ANVISA while trying to protect their pharmaceutical patents in this country.

In the decisions, Genentech and Novartis each obtained preliminary injunctions against ANVISA in cases of prior approval of their patent applications under Article 229-C of the Brazilian Patent Statute (Additional information about each of the decisions can be found here:novartisdecisiongenentechdecision).Specifically, Novartis’ patent application claims fingolimod (Gilenya) and Genentech’s application claims bevacizumab (Avastin).

Two different trial judges affirmed that ANVISA did not have the authority to examine patentability requirements under Article 229-C of the Patent Statute. In the decision involving Genentech’s application, the judge, the Honorable Diana Silva, limited ANVISA’s role during the prior approval process to only aspects involving public health. The decision also stated that the Brazilian Patent and Trademark Office, namely, the Instituto Nacional da Propriedade Industrial (INPI)is the sole legitimate agency to examine the patentability requirements of patent applications directed to pharmaceutical products.

The decision involving Novartis’ application is an important case for pharmaceutical companies facing the issues of backlog and pendency of their patent applications in Brazil. Specifically, in this case, Novartis sought a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to issue a decision regarding prior approval.Additionally, Novartis also requested preventive measures against the agency to prevent it from examining the application for compliance with patentability requirements under the Brazilian Patent Statute (which is the function of INPI).The judge, the Honorable Iolete Oliveira, accepted Novartis’ arguments and granted a preliminary injunction ordering ANVISA to:(1) analyze the prior approval of the patent application within 15 days; and (2) abstain from examining the application for compliance with any patentability requirements but focus instead only on aspects of public health.

Both of these decisions highlight that the Brazilian federal courts are willing to limit ANVISA’s role under the prior approval analysis. The Novartis case establishes important precedent that can be used by other companies currently waiting ANVISA’s decision on prior approval analysis.

Brazil’s Biodiversity Law No. 13,123 (Biodiversity Law) was signed into law on May 20, 2015. Decree No. 8,772 (Decree) was issued on May 11, 2016 to implement the statute which repealed provisional measure 2,186-16 adopted by President Fernando Henrique Cardoso in 2001 (2001 Provisional Measure). The 2001 Provisional Measure has been criticized as overly complex and bureaucratic. Nonetheless, one of the consequences of the Biodiversity Law and the Decree was the creation of several new obligations relating to the research and development of plant varieties in Brazil, particularly those resulting from the access to national genetic heritage and associated traditional knowledge.

As a result, on October 24, 2016, the Brazilian Plant Variety Protection Office (PVP Office) implemented several new procedures relating to the filing and examination of PVP applications in order to comply with the provisions of the Biodiversity Law and Decree. These new procedures can be found in English here: englishpvpprocedures.

One of the new procedures is the requirement of a declaration of access or non-access to national genetic heritage samples or associated traditional knowledge (access declaration) that might have occurred during the development of a new plant variety. An access declaration must be submitted for any new plant variety that resulted from research where access to Brazilian genetic heritage or associated traditional knowledge might have occurred as of June 30, 2000. For new applications, an access declaration will be required at the time of filing of an application. The same applies for pending applications. The PVP Office will issue an Office Action requiring the submission of the declaration before granting protection.

The PVP Office has proposed two different wordings for an applicant’s access declaration: (i) “The applicant declares that a genetic heritage or a traditional knowledge were accessed for the present protection request”; and (ii) “The applicant declares that neither a genetic heritage nor an associated traditional knowledge were accessed for the present protection request”.

In those instances where access to national genetic heritage samples occurred during the development of a new variety, the applicant must register the new variety at the Board of Management of Genetic Heritage – Brazilian Ministry of Environment (CGEN) prior to the filing of a PVP application. Failure to do so will result in the shelving of the application by the PVP Office (Article 110 of the Decree). Moreover, information relating to the registration at CGEN must be submitted at the time of the filing of the application along with the access declaration. Despite having an integrated system, the Ministry of Agriculture’s CGEN electronic filing of documents is not yet available. The PVP Office has stated that Articles 37 and 38 of the Biodiversity Law will be disregarded and applicants will have more time than the one (1) year transitional period to provide the registration information to the office.

Any use of associated traditional knowledge requires prior and informed consent from the native community providing such knowledge (Article 9 of the Biodiversity Law). Specifically, the community must be made aware of the social, cultural and environmental impact of providing such knowledge and must also be informed that it has the right to refuse the users access request (Article 16 of the Decree).

Applicants must comply with every requirement of the Biodiversity Law and Decree. Violations can result in several administrative sanctions, including fines, cancellation or shelving of an application, product seizure, interdiction of the offending applicant, etc. Specifically, the fines provided by the Decree are as follows:

Accessing traditional knowledge without the community’s prior approval: From approximately USD 30,000 to approximately USD 3 million (Article 83 of the Decree);

Failure to notify the CGEN of the marketing of finished products or reproductive materials: From approximately USD 9,000 to approximately USD 3 million, which can be doubled in case of international marketing (Article 78 of the Decree);

Sending genetic heritage abroad (outside of Brazil) without previous registry: From approximately USD 30,000 to approximately USD 3 million, which can be tripled in the case endangered species are used (Article 79 of the Decree);

Filing for patents in Brazil or abroad without previous registry: From approximately USD 6,000 to approximately USD 3 million (Article 80 of the Decree);

Disclosing results without previous registry: From approximately USD 15,000 to approximately USD 150,000 (Article 81 of the Decree); and

Failing to register the access before the marketing of intermediary products: From approximately USD 15,000 to approximately USD 150,000 (Article 82 of the Decree).

Access and benefit sharing (ABS) agreements are required for any economic use of varieties originating from access to genetic heritage or associated traditional knowledge. ABS agreements are mandatory, even if the new variety is manufactured abroad. The ABS agreements fall into two categories:

Financial: Requirement of payment to the National Fund for Benefit Sharing (FNRB) of 1% of the annual net income originating from the economic use of the genetic heritage. This amount may be reduced by up to 90% (0.1% of the net income) by filing a petition before the Environment Ministry (MMA); and

Non-financial: Technology transfer, disclosure of the product to public domain, royalty-free licensing, etc.

This is the second update to our 2014 10-part series “The Thorny Problem of Patentable Eligible Subject Matter.” Since that series, the U.S Patent and Trademark Office (USPTO) issued further guidance on December 16, 2014, updated in July 2015 and May 2016 (May 2016 Update), for evaluating subject matter eligibility under Section 101 (Guidance). The new Guidance superseded the March 4, 2014 Guidance. Part 1 – Update on Patentability of Diagnostic Claims: Australia can be found here.

On July 16, 2016, the USPTO issued a memo commenting on recent decisions by the U.S. Supreme Court (Supreme Court) and the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in two subject matter eligibility cases directed to life sciences method claims: Sequenom v. Ariosa and Rapid Litigation Management v. CellzDirect, (Rapid Litigation Management) respectively. The memo concludes that neither decision changes the subject matter eligibility framework and that the existing Guidance and training examples are consistent with these cases; however, the memo also notes that the Rapid Litigation Management decision further clarifies the inquiry involved in determining whether a claim is directed to a judicial exception. In particular, the Federal Circuit stated that the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole, was a patent-ineligible concept.”

The May 2016 Update provided more detailed instructions for Examiners regarding the formulation of a rejection under Section 101 and evaluation of an Applicants response thereto. Specifically, Examiner’s must identify the exception to patentable subject matter (referred to as a “judicial exception”) that is being claimed, explain what is recited in the claim and why it is an exception, and identify any additional elements that define claim features/limitations/steps that are beyond the exception. The Examiner must then explain why the additional elements individually AND in combination do not result in the claim as a whole amounting to “significantly more” than the exception.

The May 2016 Update also provided additional examples for application of the Guidance to specific types of life science claims, which were not well represented in the December 2014 Guidance.

As discussed in our 2014 series, Article 10 of Brazilian Intellectual Property law (IPL) defines what is not considered to be an invention or a utility model and thus, patent ineligible subject matter. In fact, Article 10 may be considered the counterpart of 35 U.S.C. § 101 in the U.S. According to Article 10, the following are not considered be patent eligible subject matter:

Literary, architectural, artistic, and scientific works or any aesthetic creation;

Computer programs per se;

Presentation of information;

Rules of games;

Operating or surgical techniques and therapeutic or diagnostic methods for use on the human or animal body; and

Natural living beings, in whole or in part, and biological material, including the genome or germplasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes.

Additionally, Article 18 of Brazilian Intellectual Property law further limits what may be patentable and indicates that the following are not patentable:

Anything that is contrary to morals, good customs, and public security, order, and health;

Substances, matter, mixtures, elements or products of any kind, as well as the modification of their physical-chemical properties and the respective processes of obtaining or modifying them, when they result from the transformation of the atomic nucleus; and

Living beings, in whole or in part, except transgenic micro-organisms* meeting the three patentability requirements provided for in Article 8 (i.e., novelty, inventive activity, and industrial application) and which are not mere discoveries.

*For the purposes of this law, transgenic micro-organisms are organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that cannot normally be attained by the species under natural conditions.

Additionally, on July 15, 2016, the Ministry of Development, Industry and Foreign Trade, National Institute of Industrial Property (INPI) published Part II of its guidelines for the examination of patent applications relating to patentability (Guidelines). According to Paragraph 1.38 of the Guidelines, a diagnostic method is not considered an invention when the series of steps that comprise the method are applied “in a human or animal body”. Specifically, Paragraph 1.39 states that:

A diagnostic method for application in the human or animal body in accordance with the provisions of item VIII of Article No. 10 of IPL falls within, when it meets the following criteria: (i) it has direct application in the human or animal body, such as, for example, in the base of determining the allergic conditions by diagnostic examination applied in the body, or requires the presence or participation of the patient for its interpretation; and (ii) allows the conclusion of the clinical state of the patient, or indicate various possible clinical states, just based on data processing, analysis or interpretation, information and/or clinical results associated with the patient.

The following is an example provided in the Guidelines of a diagnostic method not considered to be an invention (and hence not patentable):

Automated diagnostic method of a patient, characterized in that it comprises the steps of:

examining the patient to provide at least a first symptom element having a first relative degree of importance to the symptom;

examining the patient to provide at least a second symptom element having a second relative degree of importance to the symptom;

apply the relative degrees of importance for the symptoms, in order to obtain a diagnostics core for the conclusion of a medical condition.

Paragraph 1.41 of the Guidelines makes it clear that methods consisting of in vitro tests that are carried out on blood samples or other tissue removed from the body are considered to be an invention because such tests are not applied to a human or animal body and thus do not “conclude regarding the clinical state of the patient”. However, this same paragraph also notes that diagnostic methods may include a combination of in vivo and in vitro steps. In these instances, “…if the claimed method includes technical steps carried out in vivo, which are inseparable from the in vitro step, the method as a whole will be regarded as being applied on the body and, therefore, it will not be considered invention. In addition, the treatment of tissues, cells or body fluids after they have been removed from the human or animal body, or methods applied onto them, such as methods in vitro, are considered entitled to protection. The methods of measurement of enzymes and blood glucose, complete blood count, serology tests, among others, are included in this case.”

Paragraph 1.42 of the Guidelines further specifies that methods of obtaining information from a human or animal body where the data collected is just an “intermediate result that, by itself, is not enough for defining a diagnosis, are not considered diagnosing methods.” Therefore, such methods are considered to be inventions and thus entitled to protection.

We at the BRIC Wall thought it would be insightful to update our analysis of subject matter eligibility under Brazilian patent law for diagnostic method claims based on the May 2016 updated Guidance and Life Science examples.

Analysis of Life Sciences Examples from May 2016 Update to USPTO Guidance

Example 29 – Diagnosing and Treating Julitis

Background: Example 29 of the May 2016 Update relates to a hypothetical situation relating to an autoimmune disease called “Julitis.” An Applicant for a patent discovered that Julitis could be diagnosed by detecting the presence of the hypothetical “JUL-1” protein in patients’ plasma, skin, hair and nails. Applicant has disclosed detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody named “mAb-D33”).

Two representative claims from this Example are analyzed below.

Claim 1. A method of detecting JUL-1 in a patient, said method comprising:

obtaining a plasma sample from a human patient; and

detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

Claim 2. A method of diagnosing julitis in a patient, said method comprising:

obtaining a plasma sample from a human patient;

detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and

diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

Analysis of claims 1 and 2: Both claims 1 and 2 would constitute patent eligible subject matter in Brazil. In the U.S., claim 1 constitutes patent eligible subject matter, while claim 2 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the claim is directed to a judicial exception (i.e., the correlation between the presence of JUL-1 and the presence of julitis in the patient) and as a whole does not amount to significantly more than the exception itself.

Example 31 – Screening for Gene Alterations

Background: Applicant discovered the “wild-type” sequence of the human BRCA1 gene (i.e., the typical sequence of the gene in humans), and has also discovered naturally occurring alterations from the wild-type sequence that are correlated with an increased likelihood of developing breast or ovarian cancer. Applicant’s disclosure provides methods of screening patients for alterations in the BRCA1 gene by comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences.

At the time the invention was made and the application was filed, scientists routinely compared DNA sequences using two-data generating techniques: (1) hybridizing two different DNA molecules (e.g., a probe and DNA isolated from a patient sample), and detecting whether the molecules bind to each other and form a hybridization product and (2) amplifying (making copies of) at least part of a DNA molecule such as DNA isolated from a patient sample, by using a set of primers to produce amplified nucleic acids, and then sequencing the amplified nucleic acids. The probes and primers used in these techniques are short single-stranded DNA molecules that typically have a naturally occurring nucleotide sequence.

In one embodiment, Applicant discloses using a computer-implemented micromechanical method known as Scanning Near-field Optical Microscopy (SNOM) to detect hybridization of a single probe to its target. At the time the invention was made and the application was filed, the use of SNOM to study DNA hybridization had been discussed in several articles in widely-read scientific journals. However, scientists were not commonly or routinely using SNOM to study DNA hybridization at the time the invention was made and the application was filed. Instead, scientists at the time typically used autoradiography to detect hybridization products.

In another embodiment, Applicant discloses using Cool-Melt polymerase chain reaction (Cool-Melt PCR) to amplify BRCA1 DNA from the patient sample. Cool-Melt PCR uses lower melting and annealing temperatures than conventional PCR, which results in Cool-Melt PCR having a 20-fold higher sensitivity of mutation detection than conventional PCR. At the time the invention was made and the application was filed, Cool-Melt PCR was known and used by a few scientists in the field. Several years after filing the application, Cool-Melt PCR became a standard laboratory technique that appeared in virtually every laboratory manual and was conventionally used by most scientists in the field to amplify mutant nucleic acids.

Three representative claims from this Example are analyzed below.

Claim 1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids; and

sequencing the amplified nucleic acids.

Analysis of claims 1, 70, and 80: Claims 1, 70, and 80 would constitute patent eligible subject matter in Brazil. In the U.S., claim 1 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the “comparing” amounts to an abstract idea, which is a judicial exception, and the claim as a whole does not amount to significantly more than the exception itself. In contrast, claims 70 and 80 are patent eligible in the U.S., as each claim recites additional elements that distinguishes the claim from well-understood, routine, or conventional techniques in the field (i.e., SNOM and Cool-Melt PCR, respectively), and, therefore, each of claims 70 and 80 as a whole amounts to significantly more than the exception itself.

In view of the above, Brazilian patent law is less restrictive concerning the eligibility of diagnostic method claims as compared to U.S. patent law, at least for the foreseeable future.

This post was written by Lisa L. Mueller and Melissa E. Kolom of Michael Best, and Roberto Rodrigues and Anna Carolina Correa of Licks Attorneys.

In this post, the BRIC Wall Blog continues to examine the Office of the United States Trade Representative (USTR) 2016 Special 301 report (Report) reviewing the state of intellectual property rights (IPR) protection and enforcement in U.S. trading partners around the world. The Report details the results of extensive research and analysis, which led to placing eleven countries on the priority watch list and twenty-three on the watch list. Brazil remains on the Watch List in 2016.

Despite efforts to protect against online piracy, significant concerns remain over the high levels of piracy and counterfeiting in Brazil. In order to create public awareness and enact enforcement campaigns, the National Council on Combating Piracy and International Property Crimes (CNCP) was identified in past years as an effective entity for carrying out public awareness and enforcement campaigns. Unfortunately, the CNCP was underutilized and overall ineffective in 2015. In the Report, the United States urges Brazil to provide resources for intellectual property (IP) enforcement and seeks further commitments from the country on the strengthening of its IPR protection and enforcement measures.

The Report also addresses the continued problem of significant delays in the examination of patents and trademarks, which, on average, take about eleven and three years, respectively. In early 2016, the United States-Brazil Patent Prosecution Highway pilot program was enacted to expedite the patent examination process in Brazil, specifically for inventions related to the oil and gas sector. Despite this positive step forward, there is still a duplicative review of pharmaceutical patent applications by the National Sanitary Regulatory Agency (ANVISA) which lacks transparency, exacerbates delays of patent registrations for innovative medications, and prevents patent examination by the National Institute of Intellectual Property (INPI).

Furthermore, although there are laws and regulations in Brazil to protect veterinary and agricultural chemical products against unfair commercial use of undisclosed test data and other data generated to maintain marketing approval, these same laws and regulations do not apply to pharmaceutical products. Additionally, the Report notes that actions are being taken by INPI to invalidate or shorten the term of certain “mailbox” patents for pharmaceutical and agricultural chemical products. The Report concludes that the strengthening of IPR enforcement and protection for foreign and domestic right holders as well as expediting the examination of trademarks and patents is essential for continued innovation and investment in Brazil.

Although it was encouraging when Brazil implemented new laws in the mid-1990s that expanded the scope of patentability to include pharmaceutical and biotechnology inventions, the Brazilian Patent Office (INPI) has not been able to accommodate the dramatic influx of patent applications that followed. At present, a serious backlog in patent prosecution delays the examination of applications by an average of 10 years, weakening the intellectual property infrastructure in Brazil. In an attempt to address the backlog and expedite patent prosecution, several pilot programs have been introduced. These programs include the Green Patent pilot program, the implementation of Rules #151/2015 and #80/2013 and the Patent Prosecution Highway (PPH) pilot program.

Green Patent Pilot Program

The goal of this program, coined the “green” patent program, is to examine applications related to alternative energy, transportation, energy conservation, waste management, and agriculture (other qualifying technologies are listed here), in two years or less. Launched in 2012, Brazil was the first country to implement such a program. The program is currently in its 4th phase and is accepting applications filed under the Patent Cooperation Treaty (PCT).

In order to participate in the program, an applicant must submit an application that contains no more than 15 total claims (of which three are independent), and has not previously undergone technical examination. A submission of the form specific to the pilot program must be completed, and examination and publication must be requested. According to the INPI, the progress of applications in the program can be tracked online. However a limited period of time remains to participate in the Green Patent pilot program.

INPI Rule #151/2015

Rule #151/2015 of November 10, 2015, revised the conditions for requesting priority examination of a patent application. Specifically, Rule #151/2015 allows expedited patent prosecution for elderly (above 60 years of age) or ill applicants, or applicants that can show a third party is reproducing the subject matter of their patent application. Rule #151/2015 revoked the specific provision which allowed the Ministry of Health to request prioritized examination of applications involving drugs regularly purchased by the Brazilian Public Health System. However the Ministry of Health can still request priority examination of strategic drugs for the Public Health System pursuant to Rule #80/2013 (discussed below), and the Brazilian government has retained the right to prioritize the examination of applications relevant to national emergency or public interest.

For more information, an English translation of Rule #154/2015, which implements the PPH pilot program, is available: Rule154.

INPI Rule #80/2013

Rule #80/2013 of April 9, 2013, establishes the possibility of expedited examination of applications relating to the diagnosis, prophylaxis and treatment of Acquired Immunodeficiency Syndrome (AIDS), cancer or other neglected diseases. Neglected diseases include:

Chagas Disease;

Dengue / Dengue hemorrhagic fever;

Schistosomiasis;

Leprosy;

Leishmaniasis;

Malaria;

Tuberculosis;

Buruli ulcer;

Neurocysticercosis;

Echinococcosis;

Bouba;

Fascioliasis;

Paragonimiasis;

Filariasis;

Rabies;

Helminthiasis;

Manifestations from intoxications or poisonings due to poisonous and venomous animals.

There is no limitation on the use of Rule #80/2013 and any applications expedited become the responsibility of the Board of Patent – DIRPA. Determination of whether or not an application would qualify for expedited examination under Rule #80/2013 and whether or not there would be any disadvantage associated with requesting such expedited examination must be done on a case-by-case basis. Interestingly, since 2013, Rule #80/2013 has only been used 28 times.

Judicially Induced Fast-Track Examination of Patent Applications

In addition, applicants can request the Federal Courts issue an order imposing a “judicially induced fast-track” examination of a pending application. Specifically, during the last few years, several applicants have filed lawsuits in the Federal Courts requesting expedited examination of a patent application. Several applicants have been successful in obtaining injunctive relief with the Courts ordering INPI to complete examination of a pending application within 60 days. The 60 day period to conclude examination takes into consideration sections 48 and 49 of Statute #9,784/99, which provides general rules governing federal proceedings. The attached graphicsummarizes the decisions issued by each of the four intellectual property (IP) specialized courts as well as by the appellate courts. Both the 1st and 2nd Panels from the Court of Appeals for the 2nd Federal District, which are in charge of hearing appeals against decisions from the four IP specialized courts, have affirmed the decisions from the lower courts ordering INPI to expedite examination of pending applications.

Patent Prosecution Highway (PPH) Pilot Program

Implemented on January 11, 2016, the PPH pilot program is an agreement that exists between the United States Patent and Trademark Office (USPTO) and the INPI. Limited to oil and gas inventions (e.g. extraction, refining, and transportation) filed after January 1, 2013, the PPH allows expedited examination of a Brazilian application for which a corresponding U.S. application has received a Notice of Allowance from the USPTO. In order to participate, an Applicant must submit a copy of the Notice of Allowance issued by the USPTO for the related U.S. application, and pursuant to Rule #154/2015, the Applicant must also file a request using service code 277, and pay the requisite fee of R$1,775 (approximately US$420). While the PPH pilot program is an important step by the INPI in addressing the patent application backlog, the subject matter limitation to oil and gas technologies may result in future legal challenges before the Federal Courts.

Will there be any improvement in the backlog anytime soon?

Given the current political and economic crisis in Brazil, it is unlikely that applicants will see an improvement in the backlog any time soon. Moreover, the Ministry of Health will likely support launches at risk in order to have copies of lower cost drugs available in the Brazilian market. While not the best news for applicants, the worst case scenario is that pending applications will remain in the same place in INPI’s queue.

Please continue to watch the BRIC Wall Blog for updates on patent examination in Brazil.

This post was written by Lisa Mueller and Caitlin Mac Nair of Michael Best and Roberto Rodrigues of Licks Attorneys.